510(k) · Cleared
ClearedAcumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series Press-Fit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Aug 16, 2000 as substantially equivalent to K921113 (Exactech, Inc., 1993) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1993. 147 later devices descend from it.
- Decided
- Aug 16, 2000
- Review
- 30 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921113 (1993). 2 ancestors in all. 147 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK921113 Exatech MCS Porous Coated Total Hip Femoral StemExactech, Inc. · 1993
- This deviceK002141 Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit…Exactech, Inc. · 2000
- Descendant · cites it directly · 146 of its ownK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- Descendant · cites it directly · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- Descendant · 2 generations on · 60 of its ownK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 59 of its ownK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
Showing 5 of 147 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 147 · See all- K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003 · cites it directly146descendants
- K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · cites it directly145descendants
- K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004 · 2 generations on64descendants
- K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · 2 generations on60descendants
- K070479Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · 3 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921113 | Exatech MCS Porous Coated Total Hip Femoral Stem | Exactech, Inc. | 1993 | — |
| 0 (this device) | K002141 | Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch… | Exactech, Inc. | 2000 | — |
| +1 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| +1 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| +2 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| +2 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| +3 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 7 | 0 |
| 2019 | 14 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 12 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K921113 | Exatech MCS Porous Coated Total Hip Femoral StemSummary page 4…ons/contraindications for use for the proposed AcuMatch Press-Fit Femoral Components are identical to those of our predicate Exactech MCS and MCS/HA Femoral Components (#K921113,#K990197). Packaging Materials: Material ` composition Inner / Outer Trays… | 1993 |
| * | K990197 | Modulus Compatible Stability (MCS)-HA Total Hip SystemSummary page 4…aindications for use for the proposed AcuMatch Press-Fit Femoral Components are identical to those of our predicate Exactech MCS and MCS/HA Femoral Components (#K921113,#K990197). Packaging Materials: Material ` composition Inner / Outer Trays PETG… | 1999 |
What descends from it? (147)
See all 1472 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AcuMatch Press-Fit Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement, due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of the…
Read the full statement (112 words)
AcuMatch Press-Fit Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement, due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of the AcuMatch Integrated Hip System are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.
AcuMatch Press-Fit Femoral Components are intended to be used in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used in cemented applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K002141 · printed Nov 3, 2026
Cite this page
510(k) Report. “K002141: Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series Press-Fit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K002141
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026